Clinical Trials Register

Summary
EudraCT Number:	2012-002742-20
Sponsor's Protocol Code Number:	CL2-16257-101
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-03-21
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-002742-20

A.3

Full title of the trial

Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction
An 8-month, randomised double-blind, placebo controlled, international, multicentre study.

Efecto de ivabradina frente a placebo en la función cardiaca, capacidad para el ejercicio y la activación neuroendocrina en pacientes con insuficiencia cardiaca crónica y fracción de eyección ventricular izquierda preservada. Estudio multicéntrico internacional, controlado frente a placebo, aleatorizado, en doble ciego, de 8 meses de duración

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.

Efecto de Ivabradina comparado con placebo en la función del corazón y capacidad para realizar ejercicio en pacientes que tienen insuficiencia cardiaca diastólica

A.4.1

Sponsor's protocol code number

CL2-16257-101

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Laboratorios Servier S.L.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Laboratorios Servier S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Laboratorios Servier
B.5.2	Functional name of contact point	Maria DE QUINTANA
B.5.3	Address:
B.5.3.1	Street Address	Avenida de los Madroños, 33
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28043
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34917489670
B.5.5	Fax number	+34913003249
B.5.6	E-mail	maria.dequintana@es.netgrs.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S16257
D.3.2	Product code	S16257
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IVABRADINE
D.3.9.1	CAS number	155974-00-8
D.3.9.2	Current sponsor code	S16257
D.3.9.4	EV Substance Code	SUB08357MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PROCORALAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoires Servier
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S16257
D.3.2	Product code	S16257
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IVABRADINE
D.3.9.1	CAS number	155974-00-8
D.3.9.2	Current sponsor code	S16257
D.3.9.4	EV Substance Code	SUB08357MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PROCORALAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoires Servier
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S16257
D.3.2	Product code	S16257
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IVABRADINE
D.3.9.1	CAS number	155974-00-8
D.3.9.2	Current sponsor code	S16257
D.3.9.4	EV Substance Code	SUB08357MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	S16257
D.3.2	Product code	S16257
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IVABRADINE
D.3.9.1	CAS number	155974-00-8
D.3.9.2	Current sponsor code	S16257
D.3.9.4	EV Substance Code	SUB08357MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Heart failure with preserved left ventricular ejection fraction

Insuficiencia cardiaca con fracción de eyección ventricular izquierda preservada

E.1.1.1

Medical condition in easily understood language

Diastolic heart failure

Insuficiencia Cardiaca diastólica

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	LLT
E.1.2	Classification code	10008908
E.1.2	Term	Chronic heart failure
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the effect of ivabradine compared to placebo on the diastolic function, the exercise capacity and the neuroendocrine activation over an 8-month treatment period.

Evaluar el efecto de la ivabradina frente a placebo en la función cardiaca, capacidad para el ejercicio y la activación neuroendocrina tras un periodo de tratamiento de 8 meses

E.2.2

Secondary objectives of the trial

- To evaluate the effects of ivabradine compared to placebo on cardiac function and structural parameters, quality of life, NYHA classification and other biomarkers;
- To evaluate the safety and tolerance profile of ivabradine compared to placebo.

- Evaluar los efectos de la ivabradina en comparación con placebo en la función cardiaca y parámetros estructurales, calidad de vida, clasificación de la NYHA y otros biomarcadores
- Evaluar los perfiles de seguridad y tolerancia de la ivabradina frente a placebo

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Sub-study on spiroergometry attached to CL2-16257-101 study (final version of 28th November 2012): to assess the effect of ivabradine on the cardiopulmonary exercise performance in patients with chronic heart failure and preserved left ventricular ejection fraction compared to placebo over an 8-month treatment period on exercise testing based on bicycle ergometer.

Subestudio de ergoespirometría adjunto al estudio clínico CL2-16257-101 (versión final del 28 de Noviembre del 2012) para evaluar el efecto de ivabradina frente a placebo sobre la función cardíaca, la capacidad para el ejercicio y la activación neuroendocrina en pacientes con insuficiencia cardíaca crónica y fracción de eyección ventricular izquierda preservada tras un periodo de tratamiento de 8 meses mediante una prueba de esfuerzo con una bicicleta ergométrica.
Estudio de 8 meses, aleatorizado, doble ciego, controlado con placebo, internacional y multicéntrico.

E.3

Principal inclusion criteria

- Male or female patients,
- Aged 50 years or older,
- Symptomatic Chronic Heart Failure of New York Heart Association (NYHA) class II or III for at least 3 months prior to selection,
- In stable clinical condition with regards to CHF symptoms for at least 4 weeks prior to selection,
- Documented sinus rhythm and HR superior or equal to 70 bpm on a resting standard 12-lead ECG at selection and inclusion,
- Left Ventricular Ejection Fraction superior or equal to 50% and E/e? > 13 (E = early diastolic mitral flow velocity; e? = mean of mitral annular lateral and septal proto diastolic velocities) or e? lateral < 10 cm/s and e? septal < 8 cm/s or LAVI > 34 mL/m² at selection,
- Documented NT-proBNP > 300 pg/mL or BNP > 100 pg/mL at selection.

- Hombre o mujer > 0 = 50 años,
- Síntomas clínicos de insuficiencia cardíaca crónica (clase II o III de la NYHA) durante al menos 3 meses,
- Clínicamente estable respecto a síntomas de ICC durante al menos 4 semanas antes de la selección
- Sin cambios en las tratamientos para ICC o en sus dosis durante al menos 4 semanas (6 semanas para los betabloqueantes) antes de la selección.
- Documentación electrocardiográfica de ritmo sinusal en la selección y en la inclusión con una frecuencia cardiaca en reposo > o = 70 lpm
- NT-proBNP > 300 pg/mL o BNP > 100 pg/mL en la visita de selección,
- FEVI >o = 50%,
- E/e? > 13 (E = velocidad del flujo transmitral en la protodiástole, que representa el llenado pasivo del ventrículo izquierdo; e`= media de las velocidades de flujo transmitral lateral y septal en la protodiástole o del movimiento del anillo lateral y septal) (cm/seg)

E.4

Principal exclusion criteria

- Recent (less than 3 months) myocardial infarction or coronary revascularisation,
- Scheduled coronary revascularisation,
- Severe aortic or mitral stenosis, or severe aortic regurgitation, or severe primary mitral regurgitation,
- Scheduled surgery for valvular heart disease
- Congenital heart disease,
- Previous cardiac transplantation or on list for cardiac transplantation,
- Documented permanent atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function, or recent hospitalization for atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function within the last 3 months,
- Patients able to walk more than 450 meters within 6 minutes during the selection and the inclusion visits,
- Previous or current treatment with ivabradine.

- Infarto de miocardio o revascularización coronaria recientes (menos de 3 meses),
- Revascularización coronaria programada [Intervención Coronaria Percutánea (ICP) o Cirugía de Revascularización Coronaria mediante Bypass (CABG)],
- Estenosis mitral o aórtica severa, o regurgitación aórtica severa, o regurgitación mitral primaria severa,
- Cirugía programada por enfermedad cardiaca valvular,
- Enfermedad cardiaca congénita,
- Trasplante cardiaco previo o en lista de espera para trasplante cardiaco
- Fibrilación auricular permanente documentada u otra arritmia cardiaca que interfiera con la función del nódulo sinusal, u hospitalización reciente por una fibrilación auricular u otra arritmia cardiaca que interfiera con la función del nódulo sinusal en los últimos 3 meses
- Pacientes capaces de andar más de 450 metros en 6 minutos durante la visita de selección,
- Tratamiento previo o actual con ivabradina

E.5 End points

E.5.1

Primary end point(s)

Co-primary endpoints based on echocardiography (E/e'), neuroendocrine activation (NT-proBNP) and six-minute walk test

los objetivos co-primarios están basados en la relación E/e?, medida en ecocardiografía, activación neuroendocrina (nivel plasmático de NT-proBNP) y prueba de marcha de 6 minutos,

E.5.1.1

Timepoint(s) of evaluation of this end point

Co-primary endpoints measured up to M008

se evaluarán los objetivos co-primarios tras un periodo de tratamiento de 8 meses

E.5.2

Secondary end point(s)

Efficacy and safety endpoints

objetivos de eficacia y seguridad

E.5.2.1

Timepoint(s) of evaluation of this end point

All over the study

a lo largo de todo el estudio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Austria

Belgium

Brazil

Czech Republic

France

Germany

Hungary

Italy

Netherlands

Poland

Portugal

Russian Federation

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit last participant as stated in the protocol

Ultima visita del último paciente tal y como figura en el protocol

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

400

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the discontinuation of the IMP, the participant will receive a treatment and/or have access to other appropriate care by his/her doctor.

Tras la interrupción del medicamento en investigación, el paciente recibirá otro tratamiento y/o será seguido de forma apropiada por su doctor

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-04-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-04

P. End of Trial
P.	End of Trial Status	Completed

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Clinical trials